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NCT06770491
A Phase 1 Study of Y-3 in US Healthy Volunteers.
Phase 1 trial testing Y-3 for injection in Safety in 20 participants. Completed in 20 September 2025.
20 September 2025
Quick facts
| Lead sponsor | Neurodawn Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 20 |
| Start date | 4 February 2025 |
| Primary completion | 20 September 2025 |
| Estimated completion | 20 September 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Y-3 for injection — full drug profile →
- Placebo
Conditions studied
- Safety — all drugs for Safety →
- Tolerability — all drugs for Tolerability →
- Pharmacokinetic Study in Healthy Volunteers — all drugs for Pharmacokinetic Study in Healthy Volunteers →
Sponsor
Neurodawn Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 18 to 45, any sex, with Safety or Tolerability. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetic profiles of Y-3 in healthy adult volunteers in the United States. The main questions it aims to answer are: * What the pharmacokinetic profiles of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers? * If drug Y-3 (40mg and 60 mg) is safe and tolerate in the US healthy adult volunteers. Researchers will compare drug Y-3 (40 mg and 60 mg) to a placebo (a look-alike substance that contains no drug) to see what the pharmacokinetic profiles of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers and if drug Y-3 (40mg and 60 mg) is safe and tolerate in the US healthy adult volunteers. Participants will: * Take drug Y-3 (40 mg) or Y-3 (60 mg) or a placebo only once. * Answer questions regarding your medical history. * Comply with the study procedures and requests. * Complete all tests and collections of PK Sampling. * Must not have any special dietary requirements and be able to consume the food (low-fat) provided by Tranquil Clinical Research during your 4-night stay. * Must avoid excessive ( \> 8 cups per day) caffeine consumption (i.e. coffee or tea) during your time in the study. * Must not consume any food or beverage rich in grapefruit, papaya, or mango during your time in the study. * Must not take any other medications, including traditional Chinese medicines and herbal medicines, during your time in the study. * Must avoid sexual activity or use non-drug contraceptive measures (i.e. condoms) during your time in the study. * Female participants must not become pregnant while in the study. * Must not receive any vaccinations during your time in the study. * Must not donate blood for purposes outside of study procedures during your time in the study. * Must not drink alcohol during your time in the study. * Must not smoke during your time in the study. * Inform your Study Doctor if you no longer wish to participate in the study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06770491
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Neurodawn Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT07275762 — Y-4 to Treat the Postherpetic Neuralgia · Phase 2 · recruiting
- NCT07166380 — RK-4 Intracalvariosseous Injection in Treatment of Acute Large Hemispheric Infarction · Phase 1, PHASE2 · not yet recruiting
- NCT07055412 — Y-3 for Injection in Patients With Hepatic Insufficiency and Healthy Subjects · Phase 1 · not yet recruiting
- NCT07068841 — Pharmacokinetic Effect of Y-3 on Repaglinide，Warfarin and Omeprazole in Healthy Participants · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06770491 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Neurodawn Pharmaceutical Co., Ltd.
- Last refreshed: 18 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06770491.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing